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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 54 up to week 61
Awards & highlights
Study Summary
This trial will study the long-term effects of a new seizure medication.
Who is the study for?
This trial is for individuals who have focal onset seizures and completed treatment in a prior related trial (CVL-865-SZ-001). They must be able to follow the study plan, use effective contraception if of childbearing potential, and not have had severe reactions or poor tolerance to CVL-865 previously. Those with certain blood abnormalities, at risk of suicide, or needing prohibited medications can't join.Check my eligibility
What is being tested?
The trial is testing the long-term safety and effectiveness of a drug called CVL-865 when used alongside other treatments for seizures. Participants will receive this medication over an extended period to monitor how well it works and any side effects that occur over time.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be closely monitored for any adverse reactions due to long-term use of CVL-865 as part of their seizure treatment regimen.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 54 up to week 61
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 54 up to week 61
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS)
Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECGs)
+3 moreSide effects data
From 2015 Phase 2 trial • 302 Patients • NCT0226275412%
Somnolence
8%
Nausea
8%
Dizziness
4%
Nasopharyngitis
3%
Sedation
1%
Vomiting
1%
Diabetes mellitus
1%
Alanine aminotransferase increased
1%
Transient ischaemic attack
1%
Dry mouth
1%
Dyspepsia
1%
Disturbance in attention
1%
Rash
1%
Aspartate aminotransferase increased
1%
Sinusitis
1%
Diarrhoea
1%
Upper respiratory tract infection
1%
Haematuria
1%
Rash maculo-papular
1%
Altered state of consciousness
1%
Insomnia
1%
Myalgia
1%
Breast cyst
1%
Tinel's sign
1%
Rhinitis
1%
Constipation
1%
Pruritus
1%
Fungal infection
1%
Urinary tract infection
1%
Asthenia
1%
Fatigue
1%
Ear infection
1%
Headache
1%
Intraocular pressure increased
1%
Back pain
1%
Balance disorder
1%
Head discomfort
1%
Vertigo
1%
Hypersomnia
1%
Viral infection
1%
Pain in extremity
1%
Paraesthesia
1%
Panic attack
1%
Acute prerenal failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
PF-06372865
Placebo
Naproxen
Trial Design
1Treatment groups
Experimental Treatment
Group I: CVL-865 25 mgExperimental Treatment1 Intervention
Participants will receive CVL-865 tablets orally twice daily (BID) up to the maximum dose of 25 milligrams (mg) until Week 57 during the treatment period.
Find a Location
Who is running the clinical trial?
Cerevel Therapeutics, LLCLead Sponsor
35 Previous Clinical Trials
5,595 Total Patients Enrolled
1 Trials studying Seizures
150 Patients Enrolled for Seizures
Ann Dandurand, MDStudy DirectorCerevel Therapeutics, LLC
6 Previous Clinical Trials
480 Total Patients Enrolled
1 Trials studying Seizures
150 Patients Enrolled for Seizures
Eliza HuedaStudy DirectorCerevel Therapeutics, LLC
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the trial's requirements and believe I can follow them.I won't need medications that aren't allowed in the trial.I agree to use effective birth control during and for 30 days after the trial.I am able to understand and sign the consent form.You had a seizure during Trial CVL-865-SZ-001.You have already participated in the trial CVL-865-SZ-001 (NCT04244175).I am pregnant.I agree to use a condom during treatment and for 94 days after the last dose if my partner could become pregnant.Your blood test results show low levels of hemoglobin, white blood cells, neutrophils, or platelets.If you have had thoughts about hurting yourself or have made plans to hurt yourself, or if the doctor thinks you may be at serious risk of hurting yourself.I had a bad reaction or new safety concerns to the trial medication previously.
Research Study Groups:
This trial has the following groups:- Group 1: CVL-865 25 mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must one meet to participate in this research?
"This clinical investigation is enrolling 120 suitable candidates aged between 18 and 75 who experience seizures. To qualify, prospective patients must have taken part in the CVL-865-SZ-001 (NCT04244175) trial previously and demonstrate an ability to comprehend their involvement in this research as well as meet other protocol requirements such as scheduled visits and dosage regimens."
Answered by AI
At what locations is this research study being administered?
"This clinical trial is presently taking place at 9 different sites, with three of them being located in Charleston, Saint Louis and Boston. To reduce travel needs when participating, it's recommended to select the location closest to you."
Answered by AI
Has the US Food and Drug Administration granted approval to CVL-865?
"There is clinical data available to suggest a safe use of CVL-865, earning it a score of 2 on our risk assessment scale. Unfortunately, no efficacy has yet been proven in Phase 2 trials."
Answered by AI
Are there any current opportunities for enrollment in this experiment?
"On clinicaltrials.gov, this trial is no longer accepting patients; the first posting was on December 8th 2020 and it has not been updated since November 30th 2021. However, there are currently 89 other medical trials that are in search of participants."
Answered by AI
Is this research open to participants aged 45 and above?
"This clinical trial has a set age range: Participants must be aged 18 or older, but cannot exceed 75 years of age."
Answered by AI
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